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Affinity Hollow Fiber Oxygenator with Trillium Biopassive Surface

by Avecor Cardiovascular, Inc.

510(k) K973760

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK973760 Date18 Feb 1998ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0476-2008 FDA Unclassified (pre-2012) initiated 1 Oct 2007

    Unnaproved Component Resin: Affinity NT Integrated CVR Membrane Oxygenators and EL 240 Autotransfusion Blood Collection Reservoirs contain components made from an unapproved resin

    • Terminated Z-0815-04 FDA Unclassified (pre-2012) initiated 25 Mar 2004

    An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTZ
Device Class
Class II
Regulation
21 CFR Part 870.4350
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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